Senior Statistical Programmer-South Africa
Core
Lead statistical programming for clinical trials, developing and validating CDISC-compliant datasets (SDTM, ADaM) and TLFs for regulatory submissions and interim analyses.
Role type
Senior IC statistical programmer (clinical trials)
Builds
SDTM, ADaM, and TLF datasets for clinical study reports and regulatory submissions
Domain
Clinical research / Biopharmaceuticals
Required skills
SAS programming, CDISC standards (SDTM, ADaM), XML programming, Pinnacle 21 validation, ICH guidelines, clinical trial data management
Preferred skills
SAS certification, CDISC certification, French language, Master's degree
Technologies
SAS, Pinnacle 21, XML, eCRF
Responsibilities
Develop/maintain/validate aCRFs, SDTM, ADaM, and TLFs; Review SAPs and TLF shells; Support data cleaning and issue resolution; Act as Lead/Unblinded Programmer for randomization and IDMC reviews; Mentor junior programmers
Seniority
Senior, hands-on IC with lead responsibilities